Completion of Recruitment of ACCENT Trial

Release Highlights:

• Amplia Therapeutics Ltd. (ASX: ATX) has announced the successful completion of patient recruitment for its ACCENT Phase 2a clinical trial, which has evaluated the efficacy of narmafotinib in combination with standard chemotherapy for advanced pancreatic cancer. The trial reached full enrollment ahead of schedule, with a total of 53 patients recruited since January 2024, including three additional patients to replace non-evaluable cases. The company now expects to release top-line data from the study in mid-Q3 2025​.
• Preliminary results from the first 26 patients enrolled in the Phase 2a portion of the ACCENT trial have shown promising efficacy, with an additional confirmed partial response (PR), bringing the total to 10 confirmed PRs and achieving an objective response rate of 38.5%, which is significantly higher than the 23% observed in the historical benchmark trial. Additionally, the median duration on trial for these patients has reached 197 days, marking a 68% improvement over historical data, while narmafotinib continues to demonstrate a favorable safety and tolerability profile​.
• The ACCENT trial, which is being conducted at twelve sites across Australia and South Korea, consists of two stages: the completed Phase 1b stage, which determined the optimal dose of narmafotinib, and the ongoing Phase 2a stage, which is assessing its efficacy in combination with chemotherapy. The trial’s primary endpoints include objective response rate and duration on trial, with secondary measures such as progression-free survival and overall survival. Amplia’s CEO, Dr. Chris Burns, emphasized that the early completion of recruitment was a result of dedicated efforts by the company and its clinical partners, and he reiterated the company’s commitment to providing timely updates as the study progresses​.